Results 101 to 110 of about 30,003 (287)

Regulatory guideline for biosimilar products in Korea [PDF]

, 2011
The regulatory framework of biosimilar products in Korea is a 3-tiered system: 1) Pharmaceutical Affairs Act; 2) Notification of the regulation on review and authorization of biological products; 3) Guideline on evaluation of biosimilar products.
Park, Younjoo, Suh, Soo Kyung
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Biosimilars: Extrapolation for oncology

Critical Reviews in Oncology/Hematology, 2016
A biosimilar is a biologic that is highly similar to a licensed biologic (the reference product) in terms of purity, safety and efficacy. If the reference product is licensed to treat multiple therapeutic indications, extrapolation of indications, i.e., approval of a biosimilar for use in an indication held by the reference product but not directly ...
G. Curigliano, D. P. O'Connor, J. A. Rosenberg, I. Jacobs   +3 more
openaire   +4 more sources

Nanoparticle Therapeutics in Clinical Perspective: Classification, Marketed Products, and Regulatory Landscape

Small, EarlyView.
This review presents a detailed overview of clinically approved nanoparticle therapeutics, classifying them by type and discussing their unique advantages in drug delivery. It highlights regulatory challenges across global markets and emphasizes the need for adaptive approval pathways.
Nimeet Desai, Dhwani Rana, Mitali Patel, Neha Bajwa, Rajendra Prasad, Lalitkumar K. Vora   +5 more
wiley   +1 more source

Budget impact analysis of natalizumab biosimilar on pharmaceutical expenditure for the treatment of relapsing-remitting multiple sclerosis in Italy

AboutOpen
Background: The availability of high-efficacy disease-modifying therapy (DMT), including natalizumab, improved treatment efficacy in adults with highly-active relapsing-remitting multiple sclerosis (RRMS).
Roberto Bergamaschi, Marco Capobianco , Roberto Ravasio   +2 more
doaj   +1 more source

Experimental and Computational Insights into the Structural Dynamics of the Fc Fragment of IgG1 Subtype from Biosimilar VEGF‐Trap

Small Structures, EarlyView.
The constant fragment (Fc) of the immunoglobulin G1 (IgG1) subtype is a widely used scaffold for designing advanced therapeutics. Herein, together with the integration of experimental and computational techniques, this study reveals the structural dynamics of the N‐glycan‐bound Fc fragment of IgG1 from VEGF‐Trap, providing a new insight into enhancing ...
Ebru Destan, Engin Turkut, Alper Aldeniz, Jungmin Kang, Takehiko Tosha, Makina Yabashi, Baris Yilmaz, Ahmet Can Timucin, Hiroaki Matsuura, Yoshiaki Kawano, Irfan Cinkaya, Hasan DeMirci   +11 more
wiley   +1 more source

Global Inflammatory Bowel Disease: Opportunities and Challenges for a New Era

United European Gastroenterology Journal, EarlyView.
ABSTRACT Inflammatory Bowel Disease (IBD) has become a global disease. The increasing incidence of inflammatory bowel disease across the world is challenging the traditional view of IBD as a western disease and represents a unique opportunity to gain an understanding of the disease in diverse ethnic groups and in different socio‐economical and ...
Ignacio Catalan‐Serra, Shaji Sebastian
wiley   +1 more source

Ten years of biosimilar recombinant human growth hormone in Europe

Drug Design, Development and Therapy, 2017
Paul Saenger Division of Pediatric Endocrinology, Department of Pediatrics, Winthrop University Hospital, Mineola, NY, USA Abstract: Recombinant human growth hormone (rhGH) has been in clinical use for more than 30 years.
Saenger P
doaj  

Phase II study evaluating the safety and efficacy of neratinib and trastuzumab biosimilar in patients with HER2 mutated advanced solid tumors: KCSG AL20‐17/KM23 trial

Cancer Communications, EarlyView.
Kyoungmin Lee, Kyung‐Hun Lee, Dong‐Wan Kim, Jeesun Yoon, Yoon Ji Choi, Soohyeon Lee, Ju Won Kim, Kyong Hwa Park, Wonyoung Choi, Youngjoo Lee, Hyewon Ryu, Dong‐Hoe Koo, YunGyoo Lee, Hei‐Cheul Jeung, Min‐Young Lee, Namsu Lee, Myoung Joo Kang, Jieun Lee, Sook Hee Hong, Eun Joo Kang, In Hae Park   +20 more
wiley   +1 more source

Insulin Out‐of‐Pocket Spending Caps and Employer‐Sponsored Insurance: Changes in Out‐of‐Pocket and Total Costs for Insulin and Healthcare

Health Services Research, EarlyView.
ABSTRACT Objective To estimate the impact of state‐level insulin out‐of‐pocket caps on changes in out‐of‐pocket and total costs of insulin and healthcare for insulin users with employer‐sponsored insurance. Study Setting and Design We evaluated changes in costs using a quasi‐experimental (triple difference‐in‐differences; “DDD”) design to analyze multi‐
Khrysta A. Baig, Carrie E. Fry, Melinda B. Buntin, Alvin C. Powers, Stacie B. Dusetzina   +4 more
wiley   +1 more source

Glycosimilarity assessment of biotherapeutics 1: quantitative comparison of the N-glycosylation of the innovator and a biosimilar version of etanercept [PDF]

, 2018
K
Borza, Beáta, Guttman, András, Hajba, László, Szekrényes, Ákos, Szigeti, Márton   +4 more
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